Algology in Oncology Osteopathic Support (ALGOS) — ALGOS  

Breast Cancer Clinical Trial

Official title: Algology in Oncology Osteopathic Support

Status Recruiting

Clinical Trial Summary

The aim of the study is to evaluate the Impact of add-on osteopathic treatment in the algological course of patients treated for breast cancer : Randomized Controlled Trial.

Clinical Trial Description

Background: In women, the breast is the most common cancer site in the world and is unfortunately the one with the highest number of deaths. It is estimated that 30-50% of women who have undergone a mastectomy are affected by this post-operative syndrome and that 50% of patients would report chronic pain one year after surgery. Chronic pain after breast surgery (incidence of 30% at 3 months) has an essentially neuropathic component. There are many contributing factors, depending on the surgery, the patient, the analgesia technique and the treatments associated with the cancer.

Methods: The ALGOS study has received a favourable opinion from the Ethical Committee (CPP). Capsaicin patch (Qutenza 179mg) treatment as usual (TAU) is delivered in medical algological care in Oncopole, Toulouse, France. In total 120 patients meeting the inclusion criteria will be randomly assigned to one of the 3 treatment groups: One receiving osteopathic treatment before the TAU (Group 1) ; The second group receiving the OT in addition to and during the TAU (Group 2) ; The third group will receive OT after the TAU and if considered in "therapeutic failure" (Group 3). Each group will have his own control (G1C-G2C-G3C). All the patients in group 1,2,3 will receive 3 1-hour osteopathic treatment sessions in a "backbox" strategy of treatment.

The TAU by Qutenza is defined and recommended by the French health high authority. The primary outcome is the evaluation of neuropathic pain by DN4 score. The secondary outcomes include superficial fascial tissue properties of the scar by MyotonPRO, the therapeutic alliance quality will be evaluated by the Working Alliance Inventory (WAI) and the impact of pain in their quality of life by the Brief Pain Inventory (BPI score).

Discussion: If the results of the ALGOS study are positive, the study will provide arguments in favor of osteopathic treatment as a possible non-invasive additional treatment option in the multidisciplinary care support approach for patients with neuropathic pain after a breast cancer.

Trial Registration: Date: Release December-09, 2022 (positive opinion from ethical committee CPP) /N° ID-RCB: 2022-A01349-34. ;

Related Conditions & MeSH terms

• Breast Cancer
• Neuralgia
• Neuropathic Pain

• NCT number: NCT05726929
• Study type: Interventional
• Source: Institut Toulousain d'Ostéopathie
• Contact: Marie Bourguoin, MD
• Phone: +33531155753
• Email: bourgouin.marie@iuct-oncopole.fr
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Completion date: December 8, 2024